Nicotine Dissolving Film With Or Without Menthol

Abstract

A fast-dissolving film to be placed in the oral cavity of a person includes nicotine, or nicotine analog, with or without menthol, or menthol analog, that can be absorbed through the oral mucosa directly into the person's bloodstream for the purpose of reducing a temporary craving for nicotine during periods when smoking is not possible, or for therapeutic purposes, the film being thin and made from a low-moisture, non-tacky material that becomes dissolved when hydrated and that is sized so that the substrate can be placed in oral cavities of persons. From 0.1 mg to 10 mg nicotine, or a nicotine analog, and, optionally, menthol, or a menthol analog, are added to the substrate, which is then packaged in a flat, sealed container that can be unobtrusively placed into a pocket carried by the smoker, thereby making the container readily accessible to the smoker. During a period of nicotine craving encountered by the smoker when smoking is not possible, the film is removed from the container and placed into the smoker's oral cavity so that it contacts a mucosal membrane in the oral cavity of the smoker to thereby hydrate the substrate. The nicotine is thereby liberated from the film so that it can enter the smoker's bloodstream via the mucosal membrane to thereby temporarily satisfy the smoker's nicotine craving.

1 . A thin film for the delivery of a desired substance to a person's bloodstream via a mucosal membrane comprising a thin substrate of a size to be received in the person's oral cavity and made of a low-moisture, non-tacky material which rapidly dissolves when in contact with the mucosal membrane, and from 0.1 mg to 10 mg of nicotine or nicotine analog so that, upon dissolution of the substrate, the nicotine enters the bloodstream through the mucosal membrane of the person. 
     
     
         2 . A thin film according to  claim 1  wherein the nicotine present in the substrate is one of pure nicotine or a nicotine analog. 
     
     
         3 . A thin film according to  claim 1  including between 1% and 10% by weight of menthol or menthol analog in the substrate. 
     
     
         4 . A thin film according to  claim 1  wherein the substrate is made of vegetable ingredients only. 
     
     
         5 . A thin film according to  claim 1  wherein the substrate includes some animal by-products. 
     
     
         6 . A thin film according to  claim 1  wherein the substrate includes an artificial sweetener. 
     
     
         7 . A thin film according to  claim 1  wherein the substrate includes a flavoring substance. 
     
     
         8 . A thin film according to  claim 1  including a foil wrap exterior cover sealing the film from the environment. 
     
     
         9 . A thin film according to  claim 1  including a container having a thickness only slightly greater than a thickness of the film, and a removable cover placed over the container and sealing the film in the container from the exterior thereof. 
     
     
         10 . A method of providing a temporary nicotine bridge for a smoker during periods when the smoker cannot smoke comprising
 providing a thin substrate made from a low-moisture content, non-tacky material that becomes dissolved when hydrated and that is sized so that the substrate can be placed in oral cavities of persons,   adding from 0.1 mg to 10 mg nicotine, or a nicotine analog, to the substrate,   during a period of nicotine craving encountered by the smoker, placing the substrate including the nicotine or nicotine analog against a mucosal membrane of the smoker in his oral cavity, and   letting the substrate dissolve while it is in contact with the mucosal membrane to thereby liberate the nicotine or nicotine analog from the substrate so that the nicotine or nicotine analog can enter the smoker's bloodstream via the mucosal membrane.   
     
     
         11 . A method of enabling smoker to temporarily bridge a nicotine craving between a time when and at a place where smoking is not possible and when the smoker can smoke again, the method comprising
 providing a thin substrate made from a low-moisture, non-tacky material that becomes dissolved when hydrated and that is sized so that the substrate can be placed in oral cavities of persons,   adding from 0.1 mg to 10 mg nicotine, or a nicotine analog, to the substrate, packaging the substrate in a flat container,   applying a sealing, readily removable membrane over the container to seal the substrate from the environment,   unobtrusively placing the sealed container into a pocket carried by the smoker so that the container is readily accessible to the smoker,   during a period of nicotine craving encountered by the smoker when smoking is not possible, removing the substrate from the container,   placing the substrate into the smoker's oral cavity and contacting the substrate with a mucosal membrane in the oral cavity of the smoker to thereby hydrate the substrate, and   waiting for nicotine liberated from the dissolving substrate to enter the smoker's bloodstream via the mucosal membrane to thereby temporarily satisfy the smoker's nicotine craving.   
     
     
         12 . A method according to  claim 11  wherein removing the substrate comprises pulling the membrane at least partially off the container and thereafter removing the substrate from the container.